Arthritis & Rheumatism, Volume 63, November 2011 Abstract Supplement

Abstracts of the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific MeetingChicago, Illinois November 4-9, 2011.

A Randomized, Double-Blind Comparison of Duloxetine 30 Mg Once Daily (QD) and Placebo in Adult Patients with Fibromyalgia.

Arnold1, Lesley M., Zhang2, Shuyu, Pangallo3, Beth

University of Cincinnati College of Medicine, Cincinnati, OHEli Lilly and Company, Indianapolis, INELi Lilly and Company, Indianapolis, IN

Background/Purpose:

Treatment with duloxetine 60 mg QD significantly reduces pain severity in adult patients with fibromyalgia (FM) with or without major depressive disorder (MDD). In previous FM trials, 1-week treatment with duloxetine 30 mg QD resulted in statistically significant pain reduction compared with placebo before duloxetine was increased to the target dose of 60 mg QD. The present study was conducted to evaluate further the efficacy and safety of duloxetine 30 mg QD dose in adult patients with FM with or without MDD.

Methods:

This study was a double-blind, randomized, placebo-controlled, fixed dose 12-week trial of duloxetine 30 mg QD. Key inclusion criteria included fibromyalgia as defined by the American College of Rheumatology (1990) with or without MDD and baseline ratings of >=4 on the average pain severity of the Brief Pain Inventory-Modified Short Form (BPI), which was the primary measure of efficacy. Secondary measures included the Patient Global Impressions of Improvement (PGI-I), the Fibromyalgia Impact Questionnaire (FIQ) total score, and response rate (>=30% or 50% reduction in BPI average pain). Discontinuation rates and treatment-emergent adverse events were also assessed.

Results:

Of the 308 patients randomized, 155 received duloxetine and 153 received placebo. The mean age was 50.80 years and 95% of the patients were female. Duloxetine- treated patients did not have statistically significant BPI average pain reduction compared with placebo-treated patients (-2.04 vs. -1.70 respectively, P=.202). There was a significant improvement in duloxetine-treated patients compared with placebo-treated patients assessed by PGI-I endpoint score (2.97 vs. 3.35 respectively, P=.019) and the change from baseline to endpoint on FIQ total score (-14.62 vs. -9.75 respectively, P=.009). There were no significant differences between duloxetine- and placebo-treated patients in the 30% response rate at endpoint (49.7% vs. 43.1% respectively, P=.238) and the 50% response rate at endpoint (36.6% vs. 35.9% respectively, P=.902). The number of patients who completed the study did not differ between duloxetine and placebo treatment groups (78.1% vs. 71.9% respectively, P=.237), and nausea was the most common (>1%) adverse event leading to discontinuation (1.3% vs. 0.7% respectively, P=1.00).Treatment-emergent adverse events experienced by >=5% of LY2216684-treated patients and at least twice the incidence experienced by placebo-treated patients were nausea, dry mouth, somnolence and insomnia.

Conclusion:

The primary result of the study did not demonstrate the analgesic effect of the duloxetine 30 mg QD in the treatment of fibromyalgia with or without MDD. Duloxetine 30 mg QD was generally well tolerated, and there were no new safety issues identified.